6 docs tagged with "gspr"

MDR 2017/745, Annex I, Chapter I (GSPR 1–5) and equivalent provisions in IVDR 2017/746, Annex I, Chapter I. These requirements are foundational — they apply to every device regardless of type or class.

MDR 2017/745, Annex I, Chapter II (GSPR 6–22) and equivalent provisions in IVDR 2017/746, Annex I, Chapter II. These are specific technical requirements for how devices must be designed and manufactured.

MDR 2017/745, Annex I, Chapter III, Section 23 and IVDR 2017/746, Annex I, Chapter III, Section 20. These are the labelling and IFU requirements as part of the GSPR. Post-market labelling obligations are covered separately in Labelling & advertising.

Both MDR 2017/745 and IVDR 2017/746. The GSPR checklist (cross-reference table) is a mandatory component of the technical documentation under Annex II of both regulations.

MDR Annex II, Section 4 and IVDR Annex II, Section 4. The GSPR cross-reference table is a mandatory component of technical documentation linking each applicable general safety and performance requirement to the evidence of conformity.

Both MDR 2017/745 and IVDR 2017/746. Each regulation contains its own Annex I (GSPR), with mostly parallel structure and some IVDR-specific elements.